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CDC Recommendation for Hepatitis B Vaccination among Adults with Diabetes: Grading of Scientific Evidence in Support of Key Recommendations																									Related Pages
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Evidence of benefits, harms, values and preferences, and cost effectiveness were reviewed in accordance with GRADE methods to determine the recommendation category (Ahmed F, Temte JL, Campos-Outcalt D, Schünemann HJ; for the ACIP Evidence Based Recommendations Work Group (EBRWG). Methods for developing evidence-based recommendations by the Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control and Prevention (CDC). Vaccine 29(49):9171-6, 2011). Pooled data from 6 placebo-controlled randomized trials (5798 subjects) indicated a relative risk for hepatitis B infection events of 0.37 (95% CI 0.29, 0.48) among vaccinated subjects, although evidence type was downgraded for indirectness as trials did not focus on subjects with diabetes. Pooled data from 5 observational studies (285 subjects with diabetes) indicated 91.6% of subjects with diabetes achieved seroprotection, although evidence type was downgraded for imprecision due to small numbers. No serious vaccine-related adverse events were reported in any study. The Institute of Medicine found evidence supporting a causal relationship between hepatitis B vaccination and anaphylaxis in yeast-sensitive individuals; the risk of anaphylaxis following hepatitis B vaccine is estimated at 1.1 per million doses. [IOM (Institute of Medicine). 2011. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press; Bohlke K, Davis RL, Marcy SM, Braun MM, DeStefano F, Black SB, Mullooly JP, Thompson RS; Vaccine Safety Datalink Team. Risk of anaphylaxis after vaccination of children and adolescents. Pediatrics 2003;112:815-20]
GRADE Tables: Hepatitis B Vaccination Among Persons with Diabetes
Table 1. Benefits and Harms of Hepatitis B Vaccination Among Persons with Diabetesa
Benefits and Harms of Hepatitis B Vaccination Among Persons with Diabetes
Outcome
No. of subjects (# studies)
Incidence in controls
Incidence in vaccinated
Relative risk (95% CI) of hepatitis B infection events among vaccinated
Seroprotection proportion among subjects with diabetes (95% CI)
Risk difference per 1000 (95% CI), vaccinated versus not vaccinated
Number needed to vaccinate (NNV)BenefitsHepatitis B infection events
5798 (6 RCTs)
10.7%b
4.1%b
0.37 (0.29, 0.48)b
—
-67 (-76, -56)c
261dSeroprotection
285 (5 Obs)
—
—
—
91.6% (87.6%, 94.4%)
—
—HarmsSerious adverse events
6251 (6 RCTs and 3 Obs)
0.0%e
0.0%e
—
—
—
—Anaphylaxis
6251 (6 RCTs and 3 Obs)
0.0%e
0.0%e
—
—
—
—Table 1 FootnotesaSome studies include persons with and without diabetesbFollow-up ranged from 12-29 months; figures do not account for person-time of follow-up for all studies; relative risk and 95% CI calculated from RevMan software version 5.1cCalculated from GRADEprofiler software version 3.6 assuming fixed effectsdNumber needed to treat (number needed to vaccinate) calculated from modeling analysis of adults with diabetes ages ≥20 years (lifetime perspective)eNo serious events reported. Study sizes not sufficient to detect rare serious adverse events
Table 2. Type of Evidence for Hepatitis B Vaccination Benefits and Harms among Persons with Diabetesa
Type of Evidence for Hepatitis B Vaccination Benefits and Harms among Persons with Diabetes
Outcome
Design (# studies)
Risk of bias
Inconsistency
Indirectness
Imprecision
Other considerations
Evidence typeBenefitsHepatitis B infection events
RCT (6)
No serious
No serious
Yes (-1)b
No serious
No serious
2Seroprotection
Obs (5)
No serious
No serious
No serious
Yes (-1)c
No serious
4HarmsSerious adverse events
RCT (6)
Obs (3)
No serious
No serious
Yes (-1)b
No serious
No serious
2dAnaphylaxis
RCT (6)
Obs (3)
No serious
No serious
Yes (-1)b
No serious
No serious
2dTable 2 FootnotesaSome studies include persons with and without diabetesbSubjects with diabetes not focus of RCT studies; one RCT used 3 mcg dose on 0,1,2 month schedule; one study used 5 mcg dose on 0,1,2 month schedule with subcutaneous administrationcTotal number of events <300, 95% CI 0.88, 0.94dStudy sizes not sufficient to detect rare adverse events:  rate of anaphylaxis estimated 1.1 per million doses (95% CI 0.1, 3.9 per million doses); (Bohlke K. et al. *Pediatrics* 2003;112:815-20). Widespread vaccine use for 30 years has not revealed other serious adverse events (IOM (Institute of Medicine). 2011. Adverse Effects of Vaccines:  Evidence and Causality.  Washington, DC: The National Academies Press)
Table 3. Summary of Evidence for Benefits and Harms of Hepatitis B Vaccination among Adults with Diabetesa
Summary of Evidence for Benefits and Harms of Hepatitis B Vaccination among Adults with Diabetes
Comparison
Outcome
Study design (# studies)
Findings
Evidence type
Overall evidence typeHepatitis B vaccination vs. no vaccination
Hepatitis B infection events
RCT (6)
Decreased risk among vaccinated
2
2—
Seroprotection
Obs (5)
Seroprotection among subjects with diabetes similar to that among subjects without diabetes
4
——
Serious adverse events
RCT (6)
Obs (3)
No serious vaccine-related adverse events
2b
——
Anaphylaxis
RCT (6)
Obs (3)
No serious vaccine-related adverse events
2b
—Table 3 FootnotesaSome studies include persons with and without diabetesbStudy sizes not sufficient to detect rare adverse events
Table 4. Considerations for Formulating Recommendations: Hepatitis B Vaccine for Adults with Diabetes
Considerations for Formulating Recommendations: Hepatitis B Vaccine for Adults with Diabetes
Key factors
CommentsBalance between benefits and harms
Benefits are greater than potential harmsEvidence type for benefits and harms
Benefits: Evidence type 2 Harms: Approximately 30 year hepatitis B vaccine history indicates serious adverse events and anaphylaxis extremely rareValues
High values on preventable outcomesa for persons <60 years and moderate to high values for persons >60 years assigned by ACIP Hepatitis Work GroupCost-effectiveness
Vaccination is most cost effective for adults with diabetes for ages <60 yearsaPreventable outcomes consist of acute hepatitis, fulminant hepatitis, chronic hepatitis, cirrhosis, hepatocellular carcinoma, liver transplantation, deathSummary: Benefits are greater than potential harms; overall evidence is type 2. High values were placed on prevention of the morbidity and mortality of hepatitis B virus infection among adults with diabetes.
Study References
Arslanoglu I, Cetin B, Isguven P, Karavus M. Anti-HBs response to standard hepatitis B vaccination in children and adolescents with diabetes mellitus. *J Pediatric End & Metabolism* 2002;15(4):389-95.
Bouter KP, Diepersloot RJ, Wismans PJ, et al. Humoral immune response to a yeast-derived hepatitis B vaccine in patients with type 1 diabetes mellitus. *Diabet Med* 1992 Jan-Feb;9(1):66-9.
Douvin C, Simon D, Charles MA, et al. Hepatitis B vaccination in diabetic patients. Randomized trial comparing recombinant vaccines containing and not containing pre-S2 antigen. *Diabetes Care* 1997 Feb;20(2):148-51.
Li Volti S, Caruso-Nicoletti M, Biazzo F, et al. Hyporesponsiveness to intradermal administration of hepatitis B vaccine in insulin dependent diabetes mellitus. *Arch Dis in Childhood* 1998;78(1):54-7.
Marseglia GL, Scaramuzza A, dAnnunzio G, Comolli G, Gatti M, Lorini R. Successful immune response to a recombinant hepatitis B vaccine in young patients with insulin-dependent diabetes mellitus. *Diabetic Medicine* 1996;13(7):630-3.
Dienstag JL, Werner BG, Polk BF, et al. Hepatitis B vaccine in health care personnel: safety, immunogenicity, and indicators of efficacy. *Ann Intern Med* 1984 Jul;101(1):34-40.
Szmuness W, Stevens CE, Harley EJ, et al. Hepatitis B vaccine: demonstration of efficacy in a controlled clinical trial in a high-risk population in the United States. *N Engl J Med* 1980 Oct 9;303(15):833-41.
Francis DP, Hadler SC, Thompson SE, et al. The prevention of hepatitis B with vaccine. Report of the centers for disease control multi-center efficacy trial among homosexual men. *Ann Intern Med* 1982 Sep;97(3):362-6.
Szmuness W, Stevens CE, Harley EJ, et al. Hepatitis B vaccine in medical staff of hemodialysis units: efficacy and subtype cross-protection. *N Engl J Med* 1982 Dec 9;307(24):1481-6.
Crosnier J, Jungers P, Courouce AM, et al. Randomised placebo-controlled trial of hepatitis B surface antigen vaccine in French haemodialysis units: I, Medical staff. *Lancet* 1981 Feb 28;1(8218):455-9.
Coutinho RA, Lelie N, Albrecht-Van Lent P, et al. Efficacy of a heat inactivated hepatitis B vaccine in male homosexuals: outcome of a placebo controlled double blind trial. *Br Med J (Clin Res Ed)* 1983 Apr 23;286(6374):1305-8.

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								Page last reviewed:  April 15, 2016						Content source:  	National Center for Immunization and Respiratory Diseases homeACIP Home
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